Effects of Oxytocin and Lorazepam on Fear-related Intra-amygdalar Activity

NCT ID: NCT03829839

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-03

Study Completion Date

2017-08-16

Brief Summary

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High-potency benzodiazepines have strong anxiolytic effects accompanied by significant adverse effects including impaired cognitive function, drowsiness, dizziness and impaired motoric abilities. Importantly, the long-term use of benzodiazepines may produce dependence and withdrawal. Therefore, there is considerable scientific and public interest in identifying new anxiolytic agents.

The hypothalamic peptide oxytocin (OXT) has anxiolytic effects both in healthy participants and patients with anxiety disorders by decreasing fear-associated amygdala activity. However, so far no human study has directly compared the underlying anxiolytic mechanisms of OXT and established anxiolytic agents on amygdala activity. Importantly, the amygdala is not a homogenous structure but rather consists of several subdivisions with structural and functional differences.

Therefore, the rationale of the present project is to determine the effects of intranasal OXT and the high-potency benzodiazepine lorazepam on fear-associated responses in intra-amygdalar subregions.

Detailed Description

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Conditions

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Oxytocin, Lorazepam, Anti-Anxiety Agents, Physiological Effects of Drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oxytocin or PLC

Single dose of intranasal oxytocin (24 international units) or PLC.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Intranasal administration, 24 international units (IU) oxytocin

Placebo nasalspray

Intervention Type DRUG

The placebo nasalspray contain identical ingredients except for the active agent itself.

Lorazepam or PLC

Single dose of lorazepam (1mg) or PLC

Group Type ACTIVE_COMPARATOR

Lorazepam 1 mg

Intervention Type DRUG

Oral administration of 1mg lorazepam

Placebo Oral Tablet

Intervention Type DRUG

The placebo pill contain identical ingredients except for the active agent itself.

Interventions

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Oxytocin

Intranasal administration, 24 international units (IU) oxytocin

Intervention Type DRUG

Lorazepam 1 mg

Oral administration of 1mg lorazepam

Intervention Type DRUG

Placebo nasalspray

The placebo nasalspray contain identical ingredients except for the active agent itself.

Intervention Type DRUG

Placebo Oral Tablet

The placebo pill contain identical ingredients except for the active agent itself.

Intervention Type DRUG

Other Intervention Names

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syntocinon Tavor

Eligibility Criteria

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Inclusion Criteria

* healthy male volunteers
* right-handed

Exclusion Criteria

* Current or past psychiatric illness
* Current or past physical illness
* Psychoactive medication
* Sedative medication
* MRI contraindication (e.g. metal in body, claustrophobia)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Rene Hurlemann

Vice Chair of the Department of Psychiatry and Chair of the Medical Psychology Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Psychiatry, University of Bonn

Bonn, , Germany

Site Status

Countries

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Germany

Related Links

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Other Identifiers

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LOXY

Identifier Type: -

Identifier Source: org_study_id

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